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Psychopharmacology (2007) 191:1526 DOI 10.1007/s00213-006-0685-8
REVIEW
Ethical issues in child psychopharmacology research and practice: emphasis on preschoolers
Lacramioara Spetie & L. Eugene Arnold
Received: 28 June 2006 / Accepted: 18 December 2006 / Published online: 6 February 2007 # Springer-Verlag 2007
Abstract Introduction Psychoactive drug prescription for pre-schoolers has increased over the past decade and has been a controversial topic for those who prescribe, regulate, and research the use of psychotropics in this population. Children and adolescents are deemed vulnerable populations, at risk of being harmed by unethical or suboptimal practice and research and are in need of special protection. Historically, preschoolers have been therapeutic and research orphans, excluded from pharmacological studies so that the evidence base for their treatment has to be extrapolated from other ages. Within the past few decades, several ethical principles guiding pediatric psychopharmacological research have been developed. The same principles could effectively guide the treatment of these patients. Conclusion Further studies are needed to elucidate the safety and effectiveness of psychotropics, and sound ethical guidelines for their involvement in psychiatric research are needed. This article reviews some challenges facing mental health care providers involved in prescribing or researching the use of psychoactive drugs in preschoolers. Some of these challenges are general to medical treatment and research with children, and others are particular to child psychopharmacological treatment and research.
Keywords ADHD . Ethics . Preschoolers .
Psychopharmacology
Introduction
The use of psychotropic medications in children and adolescents with psychiatric problems has been increasing steadily over the past few decades, leading to a need for an empirical research evidence base and specific ethical guidelines for both prescribing and investigating psycho-tropics in the pediatric population.
The ethics of medical practice and research have long been a subject of debate and dialogue among health care providers, philosophers/ethicists, lawmakers, and state agencies. Several documents including The Nurnberg Code, The Declaration of Helsinki, the Belmont Report, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects have identified five ethical dimensions for undergoing human research: human rights, validity, distributive justice, beneficence/nonmaleficence, and respect for autonomy/justice (Yan and Munir 2004). To a great extent, the same principles also apply, with appropriate modifications, to clinical practice.
In fact, research ethical principles obviously derive partly from practice ethics,...